Australian news on Myalgic Encephalomyelitis and chronic fatigue syndrome

Uni of South Australia Xbox ‘increasing activity’ trial claims it has patient support

Update 3 September: In June I asked South Australia’s ME/CFS Australia (SA) if they were recruiting patients (as indicated by Dr Ferrar), if they have decided to endorse the study yet, what was their opinion on the study not using any criteria (i.e. Fukuda or International Consensus Criteria) and which criteria the organisation endorsed. I also asked why this booklet for GPs is on their website, when the first recommendation for management is to “gradually increase activity”?

A representative said they would not be providing a response but confirmed they are in the trial’s Stakeholder Advisory group.

Update 30 July: Response received: letter from University of South Australia‘s Human Research Ethics Committee and Research Integrity to my letter raising concerns about the use of graded exercise therapy and scientific rigour.

Update 19 July: Dr Ferrar: “The Stakeholder Advisory Group is comprised of 2 medical specialists, 3 representatives from patient organisations, two laypeople living with ME/CFS and the research team. Participant recruitment has not yet commenced. The study will begin when the protocol has been finalised by the Stakeholder Advisory Group.” No response to my questions about a lack of criteria, lack of a control group or questions about the measures.

Dr Ferrar says that state organisations will be recruiting patients for them, however this isn’t how South Australia’s ME/CFS Australia (SA) and Bridges and Pathways describe their involvement. Bridges and Pathways say it isn’t part of their research collaborations and ME/CFS SA haven’t decided on whether to endorse the study.

Here are the questions I put to the researchers and the South Australian organisations about the study:

What research criteria are you using to select patients?Dr Ferrar: The inclusion criteria for the study stipulate participants will need to have been diagnosed with CFS by a medical specialist and they will be requested to report which criteria were used for their diagnosis. Diagnostic uncertainty is an issue that has surrounded CFS research for some time, and unfortunately there still does not seem to be any consensus agreement. The inclusion criteria were designed to take a pragmatic approach which would provide the opportunity for sub-group analyses at the end of the study to determine whether diagnostic criteria were related to intervention outcomes.

How are you recruiting patients?
Participant recruitment will be primarily via existing professional networks with the South Australian ME/CFS Society and Bridges and Pathways, a support network for people with CFS in Adelaide. Several rheumatologists who regularly manage CFS clients have also offered their support for recruitment.

What is the total cost of your study?
The research proposal has been funded by the Mason Foundation for a total of $60,000. Additional in-kind funding from the University of South Australia also covers the chief investigators salaried time on the project and consumables etc.

What is the video game they will be playing?
It is interesting that you ask – as this took a lot of time and discussion with experts in the field of health-related active video gaming to decide. The console that will be used in the study will be the Xbox Kinect. The Kinect sensor will enable to participants to exercise from their chair (sitting) or standing, and has a very accurate level of motion capture. The games we will be providing will be a dance-based game called Kinect Dance Central and a sports game called Sports Rivals. These were chosen for pragmatic reasons, they are off-the-shelf easily available games, and after informal consultation with some adults of varying ages and genders with CFS, a preference to sporting and dance-type games was indicated.

How can you have a control group at 12 months if you are also using them for testing at 6 months?
The pilot study is designed so that there is a 6 months comparison of the intervention to control and after that time the waitlisted control group will then participate in the intervention for the final six months. This design is somewhat unconventional but has been used in previous studies. The six month randomised controlled trial component 1) was deemed sufficient to determine any increases in physical activity given the likely nature of varying inter-individual progression rates in this population, 2) allows comparison to control which is essential to determine whether the intervention is actually the ‘thing’ making the change. The second six months of the study 1) allows observation of long term adherence to active video game playing in the 12 month continual intervention group, and 2) allows both groups to participate which we feel is an ethical consideration.

Do you believe you have the support of the ME and CFS community?
The responses and interactions during consultation and discussion with people managing CFS and representatives from support groups such as the SA ME/CFS Society and Bridges and Pathways have been positive and this is why they have agreed to assist with recruitment. I feel it is essential to develop such interventions with the input of the ‘consumer group’ and stakeholders.

Part of the project involves forming a Stakeholder Advisory Group which will include rheumatologists, exercise physiologists and the research team, but more importantly several people from the general public who are managing CFS and at least two representatives from the SA ME/CFS Society and Bridges and Pathways; all of whom will help finalise the finer points of the intervention before it commences. The Stakeholder Advisory Group is soon to convene to finalise details. I acknowledge that perhaps some members of the ME and CFS community may not agree with all components of the study design, and I welcome any discussions with them in order to improve the proposed project.

What is your view of the PACE trial, in the UK, which looked at graded exercise therapy?
As a physiotherapist and someone who has for a majority of my professional time, which continues as an academic clinical educator, treated clients using active management strategies, do not feel GET to be an appropriate method to increase the physical activity levels of any person with a chronic condition. Unfortunately, the issues surrounding the PACE trial have clouded some people’s thoughts regarding the benefit of physical activity for people with chronic conditions such as people with CFS. This is potentially detrimental given the indisputable research surrounding the health benefits of physical activity. Having said that, is also equally important to prescribe any increases in physical activity appropriately, and as such the study we will conduct uses self-paced physical activity progression principles, allowing each participant to be in total control of their progression, just like they would be in everyday life.

Did the ethics committee have any questions about your study?
The role of Ethics Committees are to ensure the best practice in research design to protect the participants, the researchers and the wider community. As a result, ethics committees always have a very long list of questions regarding every study that is submitted for consideration. The UniSA ethics committee requested clarification about various aspects of the study, but was primarily concerned with the risk (to the participants) mitigation components of the study. The safety of the participants is my most important consideration when running this or any research study. The ethics committee were satisfied with the processes in place to reduce the potential risk to any participant involved. These include but are not limited to: mandatory general practitioner clearance to participate, low risk identified on a standardised exercise screening tool, and physical activity pacing counselling and support throughout the intervention provided by an accredited exercise physiologist.

What kind of waiver or agreement will participants sign? Will there be any warning of danger?
Ethical conduct of research requires that research participants be informed of all real or potential inconveniences and harms. The participants will be provided with a detailed Participant Information Sheet which outlines potential harms and benefits and will have the opportunity to ask questions of the research team and seek advice from their medical practitioners prior to enrolling. All participants also have the right and ability to withdraw from the study at any stage. All of these are standard practices that are required by the Ethics Committee.

Will the data be available after the study is complete?
It is anticipated the findings of the study will be presented at both a conference and published as a manuscript in an academic journal in order to disseminate the study results throughout the scientific community. We will also endeavour to have the findings publicised via local media so the general public can also be informed of the findings. In addition, it is planned the members of the Stakeholder Advisory Committee (i.e. Bridges and Pathways and SA ME/CFS Society) will assist with dissemination of findings via their networks.

What do you say to critics who would rather see the money going to biomedical research?
Part of the proposed project would be considered biomedical research. The secondary research question seeks to understand the link between allostatic load and physical activity levels in this population. The allostatic load is a proposed model of inflammation that is now thought to explain the development of many major chronic diseases such as coronary heart disease. It is hoped that the proposed study will take a small step to understand the inflammatory responses to exercise of people managing CFS, hence furthering our understanding of the disorder.

While it is important to undertake a range of research to better understand the aetiology of CFS and identify strategies that might be effective in prevention of the syndrome, which might be considered biomedical research, it is also important to evaluate management strategies to help those already suffering from the condition. This includes evaluating strategies to improve physical activity levels which will help maintain a better background level of health and may assist with increasing overall wellbeing.

ME/CFS Australia (SA) Inc

Peter Mitchell, Secretary, responded on behalf of the Management Committee:

We have no input into the design of the trial.

We are cognizant of the many faults in the PACE trial which claims, incorrectly, to demonstrate the value of GET for people with ME/CFS. We are also aware of the survey indicating the harm experienced by patients who have attempted GET.

Our organisation is therefore unequivocally opposed to the practice of GET for patients with ME/CFS, and we would not lend our support to any study that had that intention.

The background and brief overview of this research was presented to the society at a seminar in February, at which it was evident that Dr Ferrar has a good understanding of ME/CFS and the dangers of GET. Also, it is our understanding that the University of South Australia will be convening a reference group for the study, and that the reference group will include well-informed patients as well as experienced clinicians who understand the nature of ME/CFS and the harm GET can cause.

The Society will therefore decide whether or not to endorse the study after the consultation with reference groups has concluded and we have received official notification that it has been funded and there is intent to proceed.

Bridges and Pathways South Australia

Did you raise any objections about this study?

We did not know about it until it was on the [South Australian] ME/CFS Society’s website.

What is Bridges and Pathways position on graded exercise therapy?
B&P uses a biomedical model of ME/CFS and have a recognition that many people have mitochondrial (energy making) faults or immune system faults that can be increased with physical exercise and stress. These pathways can now be measured and identified using laboratory tests. We do not include graded exercise therapy as one of our recommended treatments.

Which clinical guidelines do you recommend?

We only use the 2014-2016 International ME/CFS Primer based on the Canadian Clinical criteria because we believe it most recommends the multi-system, multi-function genetic, neuroendocrine, functional, mitochondrial, multiple infection, faulty immune system and gut pathways. All these need to be managed through a systematic, patient-centred, problem solving, layered investigation process.

What would you say to anyone considering being part of the trial?

We cannot really comment, but we are very aware that many people cannot use computers or video type games because of the hypersensitivity.

This study is not part of the South Australian ME/CFS Clinical and Research Collaboration. Included in our coming activities is a conference / workshop of some of the new researchers to update them on the patient-centred, biomedical approaches to the management of ME/CFS.

Thank you for the feedback and for commenting. I hope so too, but fear that people may see the researchers saying that they have the support of patient organisations and trust them, when perhaps they should be resting instead.

Patient experience, Ramsay’s original treatment recommendations, and the US IOM report all concur that this ia a disease in which complete rest from the inception gives the best prognosis, that protracted programmes of exercise push mildly or moderately ill patients into permanent severe or very severe ME with complete disability and severe, intractable and unremitting pain, and that this is a disease, not a psychiatric disorder, in which ‘exertion of any kind, physical, cognitive or emotional, may adversely affect many organ systems’.

It is also known that in ME/CFS the aerobic muscle metabolism is not functioning, so that even slight exertion makes use of the anaerobic metabolism, with the damaging effects consequent on that.

The idea that an ‘increase in activity’ is in any way a desirable goal for a person with ME/CFS is like suggesting that a diabetic increase their sugar consumption, or a lung cancer sufferer increase how much smoking they do. It is based on a completely perverse misunderstanding of the illness.

Exertion is toxic to a person with ME/CFS …it poisons their whole system.

It follows that without exception, any person who has ME/CFS will be damaged by participation in this research; that any possibility of a longer term recovery or even improvement will be utterly wiped out.

Thanks, Sasha. this interview gives an insight into the thinking of Dr Ferrar. It seems somwhat confused in assuming increased exercise is good for ME/CFS patients. Thanks, alternatives2014. your comments are spot on.

Thank you for the feedback and for commenting, Susanna.
I want to give scientists and patient organisations the chance to explain their work and views. Hopefully we’ll hear back from SA’s ME/CFS organisation.

As the parent of a severely affected child, I am well aware of the setbacks and so harm that can be caused from just a brief period of trying to play a computer game. Many other parents will tell the same story of their children with ME. Gaming drives adrenaline and uses a lot of energy, which easily results in over exertion, particulary for a child. Gaming is a really bad idea and clearly the brainchild of brainless people with no understanding of ME whatsoever.

Andy,
I’m so sorry to hear about your child and glad to hear you are protecting them from harm.
I share your concerns that the researchers don’t understand ME and fear that their association with ME/CFS SA lends them a misleading legitimacy.
Thank you for reading and sharing your experience.
Sasha